Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Layla Stanek, St. John's Health System, Missouri
ClinicalTrials.gov Identifier:
NCT00444405
First received: March 6, 2007
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion.


Condition Phase
Low Back Pain
Recurrent Lumbar Disc Herniation
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

Resource links provided by NLM:


Further study details as provided by St. John's Health System, Missouri:

Enrollment: 4
Study Start Date: March 2007
Study Completion Date: April 2009
Detailed Description:

Lumbar disc herniations are quite common and typically improve after surgical correction. However, some patients develop recurrent herniations at the same level. Controversy exists as to why reherniated discs occur. Moreover, existing research does not settle the issue of whether a second decompression/discectomy or a repeat decompression/discectomy with pedicle screw fusion is the more successful treatment. This study is designed to compare differences in patient-reported pain, physical function, and satisfaction between the two types of surgery patients.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with recurrent lumbar disc herniation.

Criteria

Inclusion Criteria:

  • Recurrent lumbar disc herniation by MRI or CT with history of decompression at the same level in the past
  • Recurrent symptomatic history (with or without back pain) with radicular leg pain that improved following the first surgery
  • Male or female 18-75 years old
  • Flexion and extension x-rays that demonstrate an absence of sponylolisthesis or spondylolisthesis with less than 3 mm of movement

Exclusion Criteria:

  • Recurrence of disc herniation within 3 months of first decompression
  • Multiple level herniated discs
  • No history of lumbar back surgery except as in Inclusion criteria above
  • Documented severe osteoporosis or osteopenia
  • Symptoms of low back pain only
  • Diabetes mellitus
  • Patients with suspected or diagnosed psychological/psychiatric problems that could compromise the reliability of their results
  • Lumbar spondylolisthesis on flexion/extension x-rays > 3 mm
  • History of lumbar spine fractures (new or old)
  • Any concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study
  • Autoimmune diseases
  • Age less than 18 or greater than 75 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444405

Sponsors and Collaborators
St. John's Health System, Missouri
Zimmer, Inc.
Investigators
Principal Investigator: Alan M. Scarrow, MD, JD St. John's Health System, Missouri
  More Information

No publications provided

Responsible Party: Layla Stanek, Clinical Research Coordinator, St. John's Health System, Missouri
ClinicalTrials.gov Identifier: NCT00444405     History of Changes
Other Study ID Numbers: SJCNS-01
Study First Received: March 6, 2007
Last Updated: October 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by St. John's Health System, Missouri:
lumbar
disc
herniation
discectomy
fusion
spine

Additional relevant MeSH terms:
Hernia
Intervertebral Disc Displacement
Low Back Pain
Back Pain
Bone Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Pathological Conditions, Anatomical
Signs and Symptoms
Spinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014